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Efficacy and tolerability of vildagliptin in drug‐naïve patients with type 2 diabetes and mild hyperglycaemia *
Author(s) -
Scherbaum W. A.,
Schweizer A.,
Mari A.,
Nilsson P. M.,
Lalanne G.,
Jauffret S.,
Foley J. E.
Publication year - 2008
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/j.1463-1326.2008.00850.x
Subject(s) - vildagliptin , postprandial , tolerability , medicine , placebo , type 2 diabetes , endocrinology , diabetes mellitus , insulin , gastroenterology , adverse effect , alternative medicine , pathology
Aim: This study was conducted to assess efficacy and tolerability of vildagliptin in drug‐naïve patients with type 2 diabetes and mild hyperglycaemia. Methods: Multicentre, double‐blind, randomized, placebo‐controlled, parallel‐group study of 52‐week treatment with vildagliptin (50 mg q.d.) in 306 drug‐naïve patients with type 2 diabetes (A1C = 6.2–7.5%). A1C, fasting plasma glucose (FPG) and measures of prandial glucose control and beta‐cell function determined during standard meal tests were assessed. Results: Baseline A1C and FPG averaged 6.7% and 7.1 mmol/l, respectively, in patients randomized to vildagliptin (n = 156) and 6.8% and 7.2 mmol/l in those randomized to placebo (n = 150). A1C decreased modestly in vildagliptin‐treated patients (Δ = −0.2 ± 0.1%) and increased in patients receiving placebo (Δ = 0.1 ± 0.1%). The between‐group difference (vildagliptin − placebo) in adjusted mean change (AMΔ) in A1C was −0.3 ± 0.1% (p < 0.001). FPG increased in patients receiving placebo (Δ = 0.5 ± 0.1 mmol/l) and to a significantly lesser extent in vildagliptin‐treated patients (between‐group difference in AMΔ FPG = −0.4 ± 0.2 mmol/l, p = 0.032). Relative to placebo, 2‐h postprandial glucose (PPG) decreased (−0.9 ± 0.4 mmol/l, p = 0.012), and insulin secretory rate (ISR) relative to glucose [ISR area under the curve (AUC) 0–2 h /glucose AUC 0–2 h ] increased (+5.0 ± 1.2 pmol/min/m 2 /mM, p < 0.001). Mean body weight decreased by 0.5 ± 0.3 kg in vildagliptin‐treated patients and by 0.2 ± 0.3 kg in patients receiving placebo. The side‐effect profile of vildagliptin was similar to that of placebo, and one hypoglycaemic episode occurred in one patient receiving placebo. Conclusions: In drug‐naïve patients with mild hyperglycaemia, relative to placebo, 52‐week treatment with vildagliptin 50 mg q.d. significantly decreases A1C, FPG and PPG and improves beta‐cell function without weight gain or hypoglycaemia.